A Pharmacokinetic Study to Compare Sustained Release and Standard Paracetamol Formulations.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01551797
First received: February 23, 2012
Last updated: December 6, 2012
Last verified: November 2012

February 23, 2012
December 6, 2012
May 2010
October 2010   (final data collection date for primary outcome measure)
Median time to reach therapeutic plasma concentration of paracetamol [ Time Frame: Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment ] [ Designated as safety issue: No ]
Time period in hours over which plasma paracetamol concentration is elevated at or above 4 micrograms (μg)/milliliter (mL).
plasma concentrations [ Time Frame: Day 1 through Day 14 (follow-up visit) ] [ Designated as safety issue: Yes ]
paracetamol
Complete list of historical versions of study NCT01551797 on ClinicalTrials.gov Archive Site
  • Area under the plasma concentration-time curve (AUC) [ Time Frame: Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment ] [ Designated as safety issue: Yes ]
    Area under the plasma concentration-time curve from zero to 6 hours (AUC 0-6 hours), 12 hours (AUC 0-12 hours) to be determined. AUC0-t : the area under the plasma concentration-time curve from zero to time t when paracetamol remains detectable. AUC0-∞: the area under the plasma concentration time curve from zero and extrapolated to infinity time.
  • Time to maximum plasma concentration (Tmax) [ Time Frame: Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment ] [ Designated as safety issue: Yes ]
    Tmax for paracetamol to be determined.
  • Half-life of elimination (T 1/2) [ Time Frame: Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment ] [ Designated as safety issue: Yes ]
    T 1/2 of paracetamol to be determined.
  • Elimination rate (Kel) [ Time Frame: Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment ] [ Designated as safety issue: Yes ]
    Kel of paracetamol to be determined.
  • Maximum plasma concentration (Cmax) [ Time Frame: Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment ] [ Designated as safety issue: Yes ]
    Cmax of paracetamol to be determined.
  • Number of participants with Adverse Events (AEs) and Serious AEs [ Time Frame: Day 1 through Day 14 (follow-up visit) ] [ Designated as safety issue: Yes ]
    Safety evaluation
  • plasma absorption [ Time Frame: Day 1 through Day 14 (follow-up visit) ] [ Designated as safety issue: Yes ]
    paracetamol
  • Tmax [ Time Frame: Day 1 through Day 14 (follow-up visit) ] [ Designated as safety issue: Yes ]
    paracetamol
  • T 1/2 [ Time Frame: Day 1 through Day 14 (follow-up visit) ] [ Designated as safety issue: Yes ]
    paracetamol
  • Kel [ Time Frame: Day 1 through Day 14 (follow-up visit) ] [ Designated as safety issue: Yes ]
    paracetamol
  • Cmax [ Time Frame: Day 1 through Day 14 (follow-up visit) ] [ Designated as safety issue: Yes ]
    paracetamol
  • AE [ Time Frame: Day 1 through Day 14 (follow-up visit) ] [ Designated as safety issue: Yes ]
    frequency
Not Provided
Not Provided
 
A Pharmacokinetic Study to Compare Sustained Release and Standard Paracetamol Formulations.
A Proof of Principal Study to Investigate the Pharmacokinetic Profiles of Sustained Release and Standard Paracetamol Formulations

This proof of principle study will evaluate an experimental formulation of paracetamol that is being developed for eventual long lasting use. This study is also used for drug safety evaluation.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
  • Drug: Paracetamol 500 mg
    Standard Paracetamol formulation
  • Drug: Paracetamol 1000 mg
    Paracetamol Sustained Release formulation
  • Drug: Paracetamol 750 mg
    Paracetamol Sustained Release formulation
  • Experimental: Test Sustained Release (SR) Paracetamol (2000 mg)
    A single 2000 mg oral dose of SR paracetamol formulation (2 x 1000 mg) administered with 150 mL of water.
    Intervention: Drug: Paracetamol 1000 mg
  • Experimental: Test SR Paracetamol (1500 mg)
    A single 1500 mg oral dose of SR paracetamol formulation (2 x 750 mg) administered with 150 mL of water.
    Intervention: Drug: Paracetamol 750 mg
  • Active Comparator: Reference Paracetamol (2000 mg)
    Two single 1000 mg doses of paracetamol (2 x 500 mg/dose) administered orally 6 hours apart, administered with 150 mL of water.
    Intervention: Drug: Paracetamol 500 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Body Mass Index (BMI): Body Mass Index must be in the range 19-28 kg/m2.

Exclusion Criteria:

  • Disease: Current or recurrent disease that could affect the action, absorption, elimination or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders evidenced by abnormal liver function test, hepatitis serology test and liver image studies, renal insufficiency, congestive heart failure).
  • Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01551797
A2750894
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP